Vitreomacular Adhesion Including Macular Hole
Conditions
Brief summary
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
Detailed description
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.
Interventions
DRUGOcriplasmin
0.125 mg single intravitreal injection
OTHERSham injection
Sham injection
Sponsors
ThromboGenics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years of age or older and of either gender * Presence of vitreomacular adhesion * Best corrected visual acuity (BCVA) of 20/32 or worse in study eye * BCVA of 20/800 or better in the non-study eye
Exclusion criteria
* History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye * Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye * Macular hole of \> 400 µm diameter in the study eye * Presence of epiretinal membrane (ERM) * Aphakia in the study eye * High myopia (more than 8D) in study eye * History of rhegmatogenous retinal detachment in either eye * History of vitrectomy in the study eye * Previous participation in this trial or prior administration of ocriplasmin in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | Day 28 | Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | Month 24 | ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 25 study sites in the United States. The first subject was enrolled on 02 November 2011 and the last subject completed the study on 22 October 2014.
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg | 146 |
| Sham Subjects in the sham group received a single sham injection | 74 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 27 | 18 |
Baseline characteristics
| Characteristic | Ocriplasmin | Sham | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 9.99 | 68.5 years STANDARD_DEVIATION 10.94 | 69.1 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 103 Participants | 45 Participants | 148 Participants |
| Sex: Female, Male Male | 43 Participants | 29 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 132 / 146 | 57 / 74 |
| serious Total, serious adverse events | 49 / 146 | 27 / 74 |
Outcome results
Primary
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.
Time frame: Day 28
Population: Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin | Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | 41.7 Percentage (weighted across strata) |
| Sham | Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | 6.2 Percentage (weighted across strata) |
Secondary
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
Time frame: Month 24
Population: FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin | Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | 50.5 Percentage (weighted across strata) |
| Sham | Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | 39.1 Percentage (weighted across strata) |